NCT00901524

Brief Summary

The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 29, 2013

Status Verified

October 1, 2012

Enrollment Period

3 years

First QC Date

April 28, 2009

Last Update Submit

March 28, 2013

Conditions

Hepatitis

Keywords

HCV Genotype 1, 4Virological responseRibavirinPegPegIFN- alpha 2aViral Hepatitis (HCV)

Outcome Measures

Primary Outcomes (1)

  • Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.

    W72 or W96 (depending of the end of treatment)

Secondary Outcomes (1)

  • Analyze rapid virological response (W4) and early (W12).

    W4 and W12

Study Arms (1)

PegIFN- alpha 2a + RBV

NO INTERVENTION
Drug: Peg-interféron alpha 2a + ribavirin

Interventions

Peg-interféron alpha 2a + ribavirinDRUG

Pilot study, multicenter, open label

PegIFN- alpha 2a + RBV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Documented HIV infection (HIV positive)
  • HCV infection documented by a positive PCR
  • HCV Genotype 1 or 4
  • Compensated liver disease (Child-Pugh below/equal to 6)
  • Lymphocytes CD4 above 200/mm3
  • Patient not answering a treatment for hepatitis C.
  • Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)

You may not qualify if:

  • Co-infection with HBV (HBsAg positive)
  • Neutropenia below 1000/mm3
  • Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3.
  • Hemoglobin below 11 g / dL (men and women)
  • Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell
  • Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Tenon Service des Maladies Infectieuses

Paris, 75970, France

Location

Related Publications (1)

  • Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hezode C, Rosa I, Renard P, Mohamed MK, Bonnard P, Izopet J, Mallet V, Pol S, Albert ML, Fontanet A. Apolipoprotein H expression is associated with IL28B genotype and viral clearance in hepatitis C virus infection. J Hepatol. 2014 Oct;61(4):770-6. doi: 10.1016/j.jhep.2014.05.040. Epub 2014 Jun 4.

    PMID: 24905490DERIVED

Related Links

MeSH Terms

Conditions

HepatitisHepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Philippe BONNARD, MD

    Hopital Tenon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2009

First Posted

May 13, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 29, 2013

Record last verified: 2012-10

Locations

FR(1)